A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer

A randomized phase III study is going to started in Japan to compare TS-1 plus cisplatin as a neoadjuvant chemotherapy with surgery alone in patient with type 4 and large type 3 gastric cancer.A total of 300 patients will be accrued for this study from 35 institutions within five years. The primary endpoint is overall survival. The secondary endpoints are progression free survival (PFS), response rate, proportion of protocol achievement, proportion of curative resection, and adverse events.

Inclusion criteria

• histologically proven adenocarcinoma of stomach
• Borrmann type 4 or large (>=8 cm) type 3
• no evidence of distant metastasis including liver(M0)
• no evidence of para-aortic and/or retropancreatic lymph node metastasis(N0-2)
• no peritoneal metastasis and negative peritoneal lavage cytology (PLS) with laparoscopic confirmation
• no involvement of the esophagus with > 3cm
• an age of 20-75 years
• an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
• no prior chemotherapy, radiotherapy for any malignancy
• no prior surgery for gastric cancer except for endoscopic membrane resection (EMR)
• no breeding from primary tumor or gastrointestinal stenosis
• sufficient oral intake
• adequate organ function
• written informed consent

Exclusion criteria

• synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
• pregnant or breast-feeding women
• severe mental disease
• systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
• other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
• myocardial infarction within six disease-free months